Genomics Data Is Transformative for Clinical Trials

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BIO, Biomedtracker, Amplion, 2016

A three-fold increase in the rate of approval from Phase I—that’s the potential of biomarkers when used in patient selection, according to data from Informa’s BioMedTracker and Amplion’s BiomarkerBase.

Discoveries driven by genomic data could dramatically increase the number of biomarkers available for use in clinical trials. These data can be used to discover robust patient subgroups with genomic profiles that impact safety and efficacy. But while trial sponsors are incorporating genomic data in trials, these data are not being used optimally.

There is significant opportunity for sponsors to use genomic data for:

  • Inclusion/exclusion criteria
  • Safety assessments
  • Prospective, rather than retrospective study design
  • Actionable discoveries

Unfortunately, these are mostly missed opportunities, as current trial infrastructures don’t enable easy integration and application of genomic data at scale in real time.

So what’s to be done? I was fortunate to participate in a great discussion with Reinhard von Roemeling, former SVP of global oncology at Merck KGaA, Robert Ford, founder of Clinical Trials Imaging Consulting, and Michele Becci, vice president of industry strategy at Medidata. To learn more, download a recording of the webinar now.

About Author

Jason Mezey

Professor, Cornell University and Weill Cornell

Dr. Jason Mezey is a professor in the department of Biological Statistics and Computational Biology at Cornell University and Weill Cornell.